ABSTRACT
Clinical decision support systems (CDSSs) are computer systems that are designed to support clinical decision making, usually about individual patients. An example of a CDSS is the AI system that is central to the DECIDE-VerA project, which assists GPs by analysing a patient’s risk of developing cardiovascular diseases.
If a decision which involved the use of a CDSS turns out to have detrimental effects, the patient might seek compensation for the damage incurred. The involvement of a CDSS could give rise to specific questions regarding liability. On the one hand, there is the liability of the medical professional, which often depends on medical standards. This raises the question which behaviour is required by these standards. On the other hand, there is the liability of the manufacturer of the system. While the manufacturer is subject to fault-based liability rules, he could also face a claim under product liability law. Product liability regimes such as those in the US and the EU do not require the claimant to prove fault, but instead depend on the presence of a product defect.
This chapter focuses on EU product liability law, analysing whether and how it can apply to AI-CDSSs. The three main questions discussed are (i) whether damage related to AI-CDSSs could fall within the scope of this regime, which is tentatively answered in the affirmative, (ii) how the term ‘defect’ should be construed with respect to AI-CDSSs, arguing for a novel perspective on AI manufacturing defects, and (iii) whether and how a ‘causal link’ could be established, proposing the adoption of a rebuttable presumption based on normative standards.
van Staalduinen, Jan H, The Doctor and the Missing Link – EU Product Liability for Clinical (AI) Decision Support Systems (October 31, 2023).
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